First AngelMed Guardian® Implants in Asia Pacific
EATONTOWN, N.J., Aug. 18, 2020 /PRNewswire/ --
Key Highlights:
- First AngelMed Guardian® patient implants in Asia Pacific for Hydrix Medical, a subsidiary of Hydrix Limited (ASX: HYD)
- Four implants were carried out under the guidance of leading Cardiologist Dr. Leslie Lam
- This significant milestone provides a foundation for future implants under early access schemes in Singapore and Australia
Angel Medical Systems is pleased to announce the first implant of the AngelMed Guardian® device in Asia Pacific. Four implants were performed over a 3-day period last week in Singapore, and all patients have since been discharged from the hospital. Each implant procedure was supported by a Hydrix Medical field clinical engineer in Singapore with real-time remote support from Angel Medical Systems, USA.
Angel Medical Systems has developed the AngelMed Guardian®, the first implantable, patient alerting system designed to warn patients to seek medical attention for Acute Coronary Syndrome (ACS) including heart attacks. Delays in treatment contribute to the high level of mortality and morbidity from heart attacks.
Dr David Fischell, founder and Chairman of Angel Medical Systems commented, "We are very pleased with the success of these first Asia Pacific implants and excited about the large potential market opportunity. It has been a global team effort in getting to this point, and I'd like to acknowledge Dr. Lam's medical team and the teams from Hydrix and AngelMed for their hard work and dedication."
The successful implants follow Hydrix's announcement on March 13, 2020 that it had acquired an exclusive seven-year distribution agreement for eight Asia Pacific countries to distribute the AngelMed Guardian device, the world's first FDA approved implantable heart attack warning system.
Gavin Coote, Hydrix Executive Chairman said, "The AngelMed Guardian® implants are a significant milestone for Hydrix and Angel Medical Systems. This achievement demonstrates strong execution of our buy, build, invest strategy to create product revenue and earnings streams, and of equal importance, reflects progress in our aspiration to meaningfully improve a billion lives."
"The patients selected for implant in Singapore were chosen based on their previous medical history and the benefit they would derive from the AngelMed Guardian®. Hydrix Medical supplied the devices on a commercial basis to Dr. Leslie Lam whose patients were implanted at the Farrer Park Hospital Singapore under his GN-26 early access scheme permit," said Gordie Nye, Chief Executive Officer, Angel Medical Systems.
In terms of next clinical steps, these implanted devices will gather data over a two-week period to establish each patient's baseline heart signal. Each patient will then meet with Dr. Lam and a Hydrix Medical field clinical engineer with real-time remote support from Angel Medical Systems to calibrate and customize the device's alarm configuration. The device will continuously monitor these patients' heart signal to warn of an acute coronary syndrome event, including silent heart attacks.
About Angel Medical Systems, Inc.
Angel Medical Systems, Inc. was founded by Drs. Robert, Tim and David Fischell to advance life-sustaining patient care and the long-term management of High-Risk Coronary Artery Disease. The AngelMed Guardian System received approval by the U.S. Food and Drug Administration (FDA) in April 2018. The AngelMed Guardian® is an implantable cardiac monitor with patient alerting for patients who have had prior Acute Coronary Syndromes (ACS), including myocardial infarctions (heart attacks) or unstable angina and who remain at high risk for recurrent ACS events including silent heart attacks.
Forward Looking Statements
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward- looking statements. A number of risks and uncertainties, such as risks related to product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the Company's products to patients, market and physician acceptance of the Company's products, intellectual property protection and competitive product offerings, could cause actual events to differ from the expectations indicated in these forward-looking statements. You are cautioned not to put any undue reliance on any forward-looking statement. This press release is neither an offer to sell nor a solicitation of an offer to purchase any particular securities. Any such offer or solicitation will be made only pursuant to definitive legal agreements prepared specifically for such purpose. An investment in the Company's securities entails significant risks and is suitable only for sophisticated investors who can afford a loss of their entire investment; no assurance can be given that investment objectives will be achieved. In considering the performance information contained herein, you should bear in mind that past performance is not necessarily indicative of future results; there can be no assurance that the Company will achieve comparable results or that any projected returns will be met. The Company does not assume any obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events, or otherwise.
All questions should be directed to:
Sean Pisani
Marketing Manager
[email protected]
732.542.5551 ext. 199
SOURCE Angel Medical Systems
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